Browse Device Recalls
34,057 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,057 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 34,057 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalo... | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... | Class II | Microbiologics Inc |
| Dec 2, 2025 | KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... | Class II | Microbiologics Inc |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... | Class II | Microbiologics Inc |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Nov 29, 2025 | BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Fem... | Labeling error, Incorrect expiration date | Class II | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
| Nov 28, 2025 | RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStatio... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 | Certain pumps have potentially been released from service with defective grease applied to the ca... | Class II | Baxter Healthcare Corporation |
| Nov 28, 2025 | RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. S... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 27, 2025 | Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Pr... | Behind-the-ear sound processer packaging label is different then included product. | Class II | Advanced Bionics, LLC |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTP... | Cook Medical identified that products supplied in the affected device lots may have been manufact... | Class II | Cook Incorporated |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-10... | Cook Medical identified that products supplied in the affected device lots may have been manufact... | Class II | Cook Incorporated |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007... | Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR m... | Class II | Remote Diagnostic Technologies Ltd. |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288... | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed... | Class II | Beckman Coulter, Inc. |
| Nov 26, 2025 | Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immun... | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed... | Class II | Beckman Coulter, Inc. |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0... | Cook Medical identified that products supplied in the affected device lots may have been manufact... | Class II | Cook Incorporated |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 25, 2025 | Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Ca... | Butyrate tube cracks during actuation, rendering product unusable. | Class II | Ferndale Laboratories, Inc. |
| Nov 24, 2025 | Zimmer Dermatome AN, Model/Catalog Number: 88710100 | The devices may have a misaligned thickness control bar. | Class II | Zimmer Surgical Inc |
| Nov 24, 2025 | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software... | Software issue only allows Concentration Limits to be defined to one digit of precision past the ... | Class II | ICU Medical, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.